RecruitingPhase 4NCT06748001
Avapritinib Rollover Study
An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study
Sponsor
Blueprint Medicines Corporation
Enrollment
60 participants
Start Date
Nov 28, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.
Eligibility
Inclusion Criteria6
- Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period.
- Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements.
- Continue to clinically benefit from treatment with avapritinib.
- Able to give written informed consent.
- Agree to continue to use highly effective contraception as defined in this protocol.
- Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test.
Exclusion Criteria4
- Participant is participating in another interventional study.
- Participant is unwilling or unable to comply with study procedures and study restrictions.
- Participant is breastfeeding.
- Other protocol-defined criteria apply.
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Interventions
DRUGAvapritinib
Avapritinib will be administered in accordance with the parent study protocol.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06748001